None listed
Conditions
Interventions
Others : Women are classified and randomly assigned into MRI sequence groups(1st round screening/2nd round screening : AB (abbreviated)-MRI / FP (full protocol)-MRI application group and FP (full pro
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Women aged 20-75 with a history of breast cancer (in situ carcinoma or invasive breast cancer [stage 0-3]) - Women with a negative resection margin in the pathology results of the last surgical specimen from past breast cancer - Women with dense breasts with pattern C (heterogeneously dense) or D (extremely dense breasts) using AI-based Lunit INSIGHT for Mammography (version 1.1.4.3, Lunit Inc.) in the most recent mammography - Women who have not had a breast imaging test within 6 months - Women who agreed to undergo regular annual mammography, breast ultrasound, and breast MRI - If mammography, ultrasound, or breast MRI was performed within the last 1 year, the most recent test result is normal or positive (BI-RADS 1 or 2)
Exclusion criteria
Exclusion criteria: - Patients with symptoms related to current breast cancer or breast cancer recurrence (palpable mass, bloody or transparent nipple secretion, palpable mass in the axillary region, abnormal skin changes in the breast or nipple) - If you have been diagnosed with regional recurrence (axillary lymph nodes, supraclavicular and subclavian lymph nodes, internal mammary lymph nodes, etc.) or distant metastases - In case of bilateral total mastectomy - If women are receiving chemotherapy for cancer in other organs - Women during pregnancy or lactation - Glomerular filtration rate < 30 mL/min/1.73m2, or patients with renal insufficiency on dialysis - If women have severe claustrophobia - If women have a metal prosthesis that is not suitable for MR (e.g. breast tissue expander, etc.) - If there is a history of severe contrast agent side effects (e.g., anaphylactoid reaction, dyspnea, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of cancer detection rate (CDR) between breast ultrasound and abbreviated magnetic resonance imaging (AB-MRI) or breast ultrasound and full protocol magnetic resonance imaging (FP-MRI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Inferiority test between abbreviated magnetic resonance imaging (AB-MRI) and full protocol magnetic resonance imaging (FP-MRI);Comparison of invasive cancer detection rate and abnormal interpretation rate in mammography, ultrasound, abbreviated magnetic resonance imaging (AB-MRI), and full protocol magnetic resonance imaging (FP-MRI);Comparison of sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of each test;Calculation of interval cancer rate;Comparison of patient self-assessment (PRO) results between abbreviated magnetic resonance imaging (AB-MRI) and full protocol magnetic resonance imaging (FP-MRI) compared to ultrasound | — |
Countries
Korea, Republic of
Contacts
Public ContactMyoung Kyoung Kim
Samsung Medical Center
Outcome results
None listed